The U.S. Food and Drug Administration (FDA) is announcing that five perfluorinated substances used as grease-proofing agents have been voluntarily removed from interstate commerce by their manufacturers. After recent studies raised safety concerns with one type of perfluorinated chemicals, known as C8 compounds, FDA initiated a comprehensive review of the available data on C8 compounds. As a result of FDA’s initiative, manufacturers of these substances agreed to cease sale of all grease-proofing agents containing C8 perfluorinated compounds into the marketplace. This means that the affected products will no longer be sold for application on paper or paperboard intended for food contact use. This commitment is noted on FDA’s Inventory of Effective Food Contact Substance (FCS) Notifications. This Inventory is the main mechanism by which FDA informs both the public and industry of substances regulated through the FCN program. FDA will also conduct a market survey of food packaging to ensure that these compounds are no longer used in material that comes in contact with human or animal food.
For additional background information, correspondence between FDA and industry, and other resource, see
Update on Perfluorinated Grease-proofing Agents
Perfluorinated grease-proofing agents are coatings on paper wrappers and containers that come into contact with food, such as fast-food wrappers, microwave popcorn bags, and pet food bags. These coatings prevent oil and grease from foods from leaking through the packaging. Perfluorinated grease-proofing agents in various forms have been used on food contact surfaces since the 1960s.
Recent scientific studies have raised safety concerns with one type of perfluorinated chemicals, known as C8 compounds. These compounds have perfluorinated chain lengths of 8-carbons (C8) or longer. The studies indicate that these C8 compounds persist in the environment and can have toxic effects on humans and animals.
In response to these studies, FDA initiated a comprehensive review of the available data on C8 compounds and worked with several manufacturers to remove grease-proofing agents containing C8 perfluorinated compounds from the marketplace. As a result of FDA’s initiative, these manufacturers volunteered to stop distributing products containing C8 compounds in interstate commerce for food-contact purposes as of October 1, 2011. Existing supplies of these grease-proofing agents already in the marketplace and paper products with these grease-proofing agents can be used until they run out.
The industry’s voluntary action to cease using grease-proofing agents containing C8 perfluorinated compounds means that these products will be out of the marketplace in a relatively short period of time. Because the potential danger from C8 compounds is a result of chronic exposure to such substances, FDA has determined that the exposure which will occur during this sell-off period will not impact public health. The agency will also conduct a market survey to determine whether any manufacturers are still using grease-proofing agents which contain C8 compounds.
Federal law requires companies who wish to use a food contact substance to submit Food Contact Notifications (FCNs) to FDA at least 120 days prior to marketing the product. If the agency does not express any reservations about the safety of the substance in that time period, the company can then legally market the product. An effective FCN applies only to the food contact substance that is the subject of the FCN and that is manufactured or prepared by the manufacturer listed in the FCN.
Commitment Letters from Industry Documenting Cessation of Introduction into Interstate Commerce
- BASF Corporation (PDF, 46KB)
- E. I. DuPont de Nemours & Co (PDF, 289KB)
- Clariant Corporation (PDF, 445KB)
FDA Letters to Industry Acknowledging Receipt of Industry Commitment Letters
- Acknowledgement Receipt to BASF Corporation
- Acknowledgement Receipt to E. I. DuPont de Nemours & Co
- Acknowledgement Receipt to Clariant Corporation